Job Description

Job Title: Clinical Research Associate
Location: Great Lakes/Midwest Region
Type: Contract
Hours: 20+ hours/week


Overview
Seeking an experienced Contract CRA/Study Monitor to oversee oncology clinical trial site management across the Great Lakes/Midwest region, ensuring protocol/GCP compliance, data integrity, and patient safety. This is a remote (offsite) contract role requiring ~60% travel and 5+ years of oncology monitoring experience; SOCRA/ACRP certification is a plus.


Responsibilities

• General site management, including ensuring sites meet study qualifications, monitoring assigned study sites according to monitoring plans, ensuring timely data submission and query resolution.
• Conduct continuous monitoring activities (onsite and remote).
• Implement site management activities to ensure compliance with protocol, GCP, global, and local regulations to secure data integrity and patient safety.
• Serve as frontline liaison for Sponsor and sites to ensure successful collaboration.
• Respond to site questions and prepare reports.
• Prepare for and participate in calls/meetings as part of the study team matrix.
• Travel approximately 60% of the time; a valid driver’s license is necessary.

Requirements

• Strong healthcare-related background with a college degree or graduation from an accredited school of nursing.
• At least five years of oncology monitoring experience, including hematology study experience with multiple myeloma and small cell lung cancer backgrounds.
• Demonstrate professionalism, exemplary planning skills, and ability to work with autonomy and minimal supervision.
• Good communication skills, ability to identify key issues and trends, and effective problem-solving.
• Knowledge of ICH, GCP, safety, and other regulatory requirements; certification from SOCRA or ACRP is preferred.
• Computer competency and familiarity with data management systems (e.g., Medidata RAVE).

System One, and its subsidiaries including Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.

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Ref: #568-Clinical

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